Cleared Traditional

K152292 - Respire Blue Series-EF

K152292 is an FDA 510(k) clearance for Respire Blue Series-EF, manufactured by Respire Medical Holding. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K152292 · Respire Medical Holding · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
116d
Days
Class 2
Risk

K152292 is an FDA 510(k) clearance for the Respire Blue Series-EF. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Respire Medical Holding (Brooklyn, US). The FDA issued a Cleared decision on December 7, 2015 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K152292

510(k) Number K152292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2015
Decision Date December 07, 2015
Days to Decision 116 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 128d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRK Device Classification - Class 2, Special Controls

Product Code LRK Device, Anti-snoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

Quality Solutions and Support, LLC
Stephen W Inglese

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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All 207
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